Consider this: 400+ life-sized pediatric congenital heart disease models have been used to help save lives by improving pre-surgical planning and also potentially reduce the operative time for patients. These models were created using 3D printing (3DP) technologies in a joint effort between researchers at Arizona State University, St. Joseph’s Hospital and Medical Center, and Phoenix Children’s Hospital. Pediatric heart modeling is just one of many applications 3DP has provided for the medical industry.
“A thorough understanding of the risks and a well-planned approach to expansion will help make the journey to the end much more probable and fulfilling”
3DP continues to see rapid growth, and one of the key industries where the most growth is forecasted is healthcare Overall, the global 3DP market for healthcare is forecasted to have a CAGR of 26.2 percent from 2016 – 2020, growing to $2.3B. There have been several recent well publicized use cases in healthcare 3DP, such as customized prosthetics and implants, made-to-order jigs and instruments for use in operating rooms and innovative new drug forms with personalized release profiles. These personalized implants, fixtures and surgical tools can have a positive impact on the time required for surgery, patient recovery time and success of the surgery or implant (Banks J. Adding value in additive manufacturing: Researchers in the United Kingdom and Europe look to 3D printing for customization. IEEE Pulse. 2013;4(6):22–26.). Moreover, evidence has shown in other sectors such as industrial design, 3D printed components can be produced up to 70 percent faster, as items can be designed one day and printed overnight for use the next. In the medical sector, this is potentially beneficial for urgent, time sensitive medical cases where turnaround time is critical. Given the realized and potential clinical and economic benefits, it is not surprising many companies providing 3DP solutions are considering moving into the healthcare space.
While the potential benefits are impressive, a vertical expansion into the healthcare industry must be carefully thought through. The industry has many critical unique factors to consider, such as regulatory requirements, safety concerns, legal and privacy issues as well as factors specific to 3DP such as software, technology and materials used for creating the solution. Figure 1 illustrates key consideration factors for expansion into healthcare.
These factors are described in more detail below:
• Printing Software and Printing Materials – Solutions for clinical use generally must meet more stringent requirements. The technology and material used to deliver the solution largely depends on your 3DP application. For example, pre-surgical models for vascular surgery will prefer flexible materials, while implants such as cranial plates or knee replacements require biocompatible metals made from Selective Laser Sintering or Electron Beam Melting technologies.
• Regulatory Requirements (FDA) – The healthcare industry is one of the most highly regulated industries, though regulation and knowledge of it around 3DP medical devices remains scarce. Depending on the application, you may need to secure FDA approval for your solution. For 3DP drugs, the FDA requires adequate and well-controlled clinical investigations showing the new drug is safe and effective under the conditions of use in its proposed labeling. For 3DP devices, the FDA will “clear” a medical device for marketing if it is substantially equivalent (i.e. at least as safe and effective) as a legally marketed, or predicate, device (See 21 C.F.R. § 807.92(a)(3)).).
• Regulatory Requirements (Privacy) – A key part of the 3DP process involves collecting and transferring medical images, among other patient data. Mandates for ensuring health data security have been issued by the federal government such as Health Insurance Portability and Accountability Act (HIPAA), where healthcare institutions are obligated to take measures to ensure patient information is only provided to those who have a professional need. Guidelines, such as digital imaging and communication in medicine (DICOM) standards that deal with security issues, are continuing to be published by organizing bodies in healthcare.
• Payer Reimbursement – 3DP medical devices will be eligible for reimbursement by the government or private insurance companies if they are determined to be medically necessary and provide substantial clinical benefit. By understanding the reimbursement process and demands of payers, 3DP companies can organize clinical trials and take regulatory pathways that will support reimbursement, and in turn, help progress this new technology. The key is to impress upon payers that the 3DP device is distinguishable or novel from other devices on the market, and that it will outperform or have equal performance as current devices.
Additional key areas to understand include intellectual property and liability. IP becomes especially important as more players enter into 3DP; copyright protection generally can be obtained for CAD files, and patents obtained for novel products or processes, according to various reports by Chisum, Nimmer and Viscounty. Liability is a challenging area, as the “products” involved in the 3DP process do not align with the traditional “manufacturer” based chain of sale on which strict liability has been based. Plaintiffs are likely left with pursuing negligence claims as courts currently do not consider computer code for 3D printed designs to be a product (U.S. v. Aleynikov, 676 F.3d 71, 73 (2d Cir. Apr. 11, 2012).) nor do they impose liability on defendants whose main objective is to provide services (e.g. hospitals). Thus, companies that provide 3DP solutions must understand, prepare for, and warn offoreseeable dangers given the inherent risks presented by medical devices, particularly Class III, which sustain or support human life. These areas will continue to evolve as 3DP disrupts traditional methodologies.
The road ahead
While there are many advanced technologies today which can be used to benefit the healthcare industry, 3DP technologies have already demonstrated genuine remarkable improvements in patient health. The road to success in providing these medical miracles has a number of challenges, but a thorough understanding of the risks and a well-planned approach to expansion will help make the journey to the end much more probable and fulfilling.